The effects of Pine Bark Extract supplementation and Weight Loss Diet On Resting Energy Expenditure, Body Composition and Metabolic Syndrome criteria in Obese Women
The aim of this study is the examination of pine bark extract supplementation and weight loss diet on resting energy expenditure, body composition and metabolic syndrome criteria in obese women.
Inclusion criteria are being female, age of 18-45 and body mass index of 30-35. Exclusion criteria are included of failure to follow the weight loss diet, unwillingness to cooperate, presence of any clinical disorders and pregnancy.
Fifty obese healthy women will enroll in this randomized clinical trial study who randomly allocate in 2 groups. Both of groups receive weight loss diet in addition to 150 mg pine bark extract in intervention group and placebo in control group (starch powder) over a 2 month period. The body composition (Bioelectrical Impedance Analysis method), Resting Energy Expenditure (indirect calorimetric method) and metabolic syndrome criteria (Triglyceride, Weight circumstance, Cholesterol, Blood pressure, Blood sugar) will measure at the beginning and end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062628637N1
Registration date:2016-07-07, 1395/04/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-07, 1395/04/17
Registrant information
Name
Mohsen Sedighiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
m-sedighiyan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
- Tehran University Medical of Sciences
- Endocrinology and Metabolism Research Institute
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Pine Bark Extract supplementation and Weight Loss Diet On Resting Energy Expenditure, Body Composition and Metabolic Syndrome criteria in Obese Women
Public title
The effects of pine bark extract and weight loss diet on obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: body mass index (BMI) > 30 and <35 kg/m2; age of 18-45; being female
Exclusion criteria: Report any side effects; Unwillingness to cooperate; Use of less than 90 percent of supplements during the study intervention; Failure to follow the regime; Pregnancy, lactation or menopause; Use of any medication; Presence of any clinical disorders
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrinology and Metabolism Research Institute
Street address
Floor 5, Shariati Hospital, Kargar Shomali Street
City
Tehran
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
IR.TUMS.EMRI.REC.1394.007
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Waist circumstance
Timepoint
at the begining and end of study
Method of measurement
meter (cm)
2
Description
Systolic Blood Pressure
Timepoint
at the begining and end of study
Method of measurement
Barometer (mmhg)
3
Description
Diastolic Blood Pressure
Timepoint
at the begining and end of study
Method of measurement
Barometer (mmhg)
4
Description
serum HDL-c
Timepoint
at the begining and end of study
Method of measurement
enzymic (mg/dl)
5
Description
serum triglyceride (TG)
Timepoint
at the begining and end of study
Method of measurement
enzymic (mg/dl)
6
Description
Fasting Blood Sugar (FBS)
Timepoint
at the begining and end of study
Method of measurement
enzymic (mg/dl)
7
Description
Resting Energy Expenditure
Timepoint
at the begining and end of study
Method of measurement
indirect calorimeteric
8
Description
fat mass
Timepoint
at the begining and end of study
Method of measurement
Bioelectrical Impedance Analysis (BIA)
9
Description
fat free mass
Timepoint
at the begining and end of study
Method of measurement
Bioelectrical Impedance Analysis (BIA)
10
Description
total body water
Timepoint
at the begining and end of study
Method of measurement
Bioelectrical Impedance Analysis (BIA)
Secondary outcomes
1
Description
weight
Timepoint
at the bigining and at the end of study
Method of measurement
seca scale
2
Description
Hip circumstance
Timepoint
at the bigining and at the end of study
Method of measurement
meter (cm)
3
Description
Waist to Hip ratio (WHR)
Timepoint
at the bigining and at the end of study
Method of measurement
Calculation
4
Description
Body Mass Index (BMI)
Timepoint
at the bigining and at the end of study
Method of measurement
Calculation
Intervention groups
1
Description
The هntervention group receive one capsule with 150 mg pine bark extract, daily, for 2 month + wight loss diet
Category
Treatment - Drugs
2
Description
The control group receive one capsule contain of starch powder, daily, for 2 month + wight loss diet
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Institute in Shariati hospital
Full name of responsible person
Ms. Ehsaneh Taheri
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr. Hossein Adibi
Street address
floor 5, Shariati hospital, Kargar Shomali street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Ms. Fatemeh Javadi
Street address
44 Hojat Dost St, Naderi St, Enghelab Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Mr. Mohsen Sedighiyan
Position
Msater of Sciences of Nutrition Sciences and dietetics